A Randomized Pilot Trial Investigating a Novel Mobile Application for Practicing Exercises from ACT (NCT06647121)
A Randomized Pilot and Feasibility Trial Investigating a Mobile Application-Delivered Mindfulness Exercise for Navigating Psychological Distress: Dropping Anchor Delivered As a Stepwise Image Sequence
🩺 Plain-English Summary (8th-Grade Level)
Mindfulness-related skills are associated with positive mental health outcomes and can be effectively taught through mobile apps. However, further research is needed to determine how best to support skill acquisition through the delivery of mindfulness exercises via smartphone apps. ACTaide is a novel mobile app designed to support home practice of mindfulness-related skills through exercises presented as stepwise annotated image sequences. The primary objective of this pilot and feasibility trial is to evaluate the feasibility of a prototype version of ACTaide. This two-arm parallel single-blinded (blinded participants) pilot trial will be conducted virtually with distressed Canadian adults. Participants (N = 60) will be recruited through the online platform Prolific. The intervention group will receive an Acceptance and Commitment Therapy (ACT) psychoeducational workshop and access to ACTaide for two weeks to support home practice of a mindfulness exercise from ACT: dropping anchor. The control group will receive the same psychoeducational workshop and access to a reminders-only mobile app to support their practice of the dropping anchor exercise. The main outcome measures will assess intervention feasibility, including adherence to the intervention, acceptability of the app, and retention rates. In addition, measures related to mindfulness-related skills and psychological distress will be collected. Prespecified progression criteria will be used to determine whether and how to proceed to a future trial designed to investigate the efficacy of ACTaide.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (1 items).
Location: McGill University — Montreal, Quebec
Age range: 18 Years
🧪 Interventions in This Study
- ACT Psychoeducational Workshop (BEHAVIORAL)
- ACTaide Mobile App (BEHAVIORAL)
- Reminders-only mobile app (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria: Due to the limited psychotherapeutic scope of the intervention, individuals were ineligible if they self-reported extremely severe psychological distress (i.e., an overall score of 82 or higher on the DASS-21) or a diagnosis of a severe mental illness (i.e., bipolar disorder, psychosis, schizophrenia, borderline personality disorder).
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- McGill University — Montreal, Quebec
📞 Contact the Study Coordinator
Phone: (613) 200-6806
Email: aidan.smyth@mail.mcgill.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.